Traditional oral dosage drug formulations include both active pharmaceutical ingredients (API) and inactive ingredients. The inactive ingredients (also called excipients), are components of the final formulation of a drug that are not considered active pharmaceutical ingredients (API) in that they do not directly affect the consumer in the desired medicinal manner. Traditional oral dosage forms have several inactive ingredients. Among the traditional inactive ingredients included in oral dosage forms are binders that hold the tablet together, coatings configured to mask an unpleasant taste, disintegrants configured to make the tablet break apart when consumed, enteric coatings, fillers that assure sufficient material is available to properly fill a dosage form, enhancers configured to increase stability of the active ingredients, preservatives aimed at preventing microbial growth, and the like.
The above-mentioned inactive ingredients have also been used to develop controlled release oral dosage solid formulations. These controlled release oral dosage solid formulations are designed to temporally control the release of the API from the oral dosage drug formulation. This temporal control allows for a time delayed release, or an extended release of a desired API formulation. The selection and optimization of the inactive ingredients to obtain an oral dosage solid form with the desired controlled release properties is both a complex and a lengthy process.
In addition to the complexity and difficulty traditionally associated with selecting and optimizing inactive ingredients to obtain an oral dosage solid form with controlled release properties, there are a number of relatively insoluble drugs that are not well suited to sustained or controlled delivery. The formulation of these low water soluble or insoluble APIs into controlled or modified-release dosage forms using traditional formulation methods is both expensive and challenging due to the API's solubility properties.